Protecting the people behind biomedical big data

18 February 2015

A new report from the Nuffield Council on Bioethics says that failure to engage effectively with the public risks
undermining the potential value of biomedical data projects.

Biomedical and technological developments have
created a rapidly increasing volume of biological and health data. Combined
with new methods of analysing biomedical big data of this kind, the potential
for both valuable research and improved healthcare is enormous. There is
therefore understandable enthusiasm for initiatives to store, share and
interrogate data. Recent examples focus on genomic data, such as the 100,000 Genomes Project and Scottish
Genomes Partnership, but these in turn build on
links with electronic clinical information. Health records databases have
themselves been the focus of focused initiatives such as the the Scottish Informatics Programme
(SHIP) and the more
contentious NHS England care.data
programme.

However, the new Nuffield Council report, The collection, linking and use of data in
biomedical research and health care: ethical issues, says that public participation must be a central element of big data
projects of this kind. This recommendation has an ethical, but also a highly
practical basis; the Working Party
behind the report warned that failure to take public preferences and
values into account could undermine public trust and ultimately limit both
participation and the resulting value of data projects.

The report notes that the potential value includes the capacity to
improve healthcare by generating a robust biomedical evidence base for better
and more personalised approaches to disease prevention, diagnosis and treatment.
There is also scope to create new efficiencies in health service delivery and
underpin biomedical innovation and economic growth - aims dear to the UK
government, as set out in the 2012 NHS Innovation, health and wealth report.

However, risks include loss of privacy and security; impaired medical
care where data is not appropriately shared; discrimination and other forms of data
misuse. For example, there have been reportsthat the care.data programme failed to act on patient requests to
opt-out due to concerns that their health records could be used by insurers or
other companies.

The report notes that many potential harms of this kind are both
under-reported and inadequately addressed by current legal or regulatory
measures. It therefore calls for more research into the misuse of health data
and UK safeguards including the introduction of robust
criminal penalties for the deliberate misuse of data ‘whether or not it
results in demonstrable harm to individuals’.

Finally, the report also calls for improved governance of
biomedical data initiatives, including transparency about how people's data are
used, clear explanation of the limits of privacy, disclosure of privacy
breaches, ongoing active protection of the rights and interests of participants
and accountability for failures to do so, concluding that:

'To marginalise individuals
who provide data means risking the trust of current and future generations,
exposing people to unacceptable risks, and ultimately missing out on the
benefits of research.’

Professor Martin
Richards of the University of Cambridge, who chaired the Nuffield Council on
Bioethics Working Party behind the report, said: "There is a strong public interest in the responsible use of data
to generate knowledge, drive innovation and improve health. However, people
understandably have concerns about their privacy. If we don't get this right,
we risk losing public trust in research, and ultimately missing out on the
benefits this t ype of research can bring".